BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR

    MDR report key: 21885664 · Received April 22, 2025

    Report

    Report Number
    3012236936-2025-000111
    Event Type
    Injury
    Date Received
    April 22, 2025
    Report Date
    April 22, 2025
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    UDI-DI
    05050474573413
    PMA / PMN Number
    P910062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION E1: ADDRESS LINE 1 - (B)(6). SECTION E1: ADDRESS LINE 2 - (B)(6). SECTION H3: THE SYSTEM WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE DEVICE SERIAL NUMBER IS UNKNOWN. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. CITATION: ZOU, H., WEI, X., LI, L., WEI, D., MAO, H., HUANG, Y., LU, P., LI, Z., ZHONG, D., & CHEN, Q. (2024). COMPARISON OF OBJECTIVE VISUAL QUALITY BETWEEN SMILE AND FS-LASIK IN MODERATE-TO-HIGH MYOPIA. FRONTIERS IN MEDICINE, 11. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    LITERATURE TITLE: COMPARISON OF OBJECTIVE VISUAL QUALITY BETWEEN SMILE AND FS-LASIK IN MODERATE-TO-HIGH MYOPIA. A PROSPECTIVE STUDY WAS DONE TO COMPARE THE CHANGES IN THE CORNEAL WAVEFRONT ABERRATIONS AND THE OBJECTIVE VISUAL QUALITY RESULTING FROM TWO TYPES OF EYE SURGERY¿SMALL INCISION LENTICULE EXTRACTION (SMILE) AND FEMTOSECOND LASER-ASSISTED IN SITU KERATOMILEUSIS (FS-LASIK)¿IN PATIENTS WITH MODERATE-TO-HIGH MYOPIA. A TOTAL OF 186 EYES OF 96 PATIENTS WITH MODERATE-TO-HIGH MYOPIA UNDERWENT REFRACTIVE SURGERIES, INCLUDING SMILE (N=98 EYES OF 51 PATIENTS) AND FS-LASIK (N=88 EYES OF 45 PATIENTS). IN THE FS-LASIK, THE CORNEA FLAP WAS CREATED USING THE INTRALASE IFS 150 FEMTOSECOND LASER (ABBOTT MEDICAL OPTICS, AMO) AND THE EXCIMER LASER CUTTING WAS PERFORMED WITH AN EXCIMER LASER MACHINE VISX STAR S4 EXCIMER LASER SYSTEM (ADVANCED MEDICAL OPTICS INC.). CORNEAL HIGHER-ORDER ABERRATION PARAMETERS FOR THE FS-LASIK GROUP WERE REPORTED AS FOLLOWS WHICH WERE ASSESSED BY THE AUTHORS AS SIGNIFICANT FROM PREOPERATIVE VALUES: 1. TOTAL HIGHER-ORDER ABERRATION (THOA). PRE-OP: 0.41 ± 0.09 POST-OP DAY 1: 0.81 ± 0.34 2. PISTON PRE-OP: 1.39 ± 0.61 POST-OP DAY 1: 0.58 ± 1.41 3. VERTICAL TREFOIL PRE-OP: -0.01 ± 0.11 POST-OP DAY 1: 0.04 ± 0.13 4. VERTICAL COMA PRE-OP: -0.11 ± 0.15 POST-OP DAY 1: -0.28 ± 0.40 5. HORIZONTAL COMA PRE-OP: 0.03 ± 0.16 POST-OP DAY 1: -0.04 ± 0.3 6. SPHERICAL ABERRATION PRE-OP: 0.28 ± 0.08 POST-OP DAY 1: 0.47 ± 0.23. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED. THIS REPORT IS FOR THE EXCIMER LASER. ANOTHER REPORT IS SUBMITTED FOR INTRALASE FEMTOSECOND LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726825 STAR S4 IR EXCIMER LASER SYSTEM LZS AMO MANUFACTURING USA, LLC UNK-EXCIMER 05050474573413

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown